Omega-3 fatty acid articles of manufacture, and methods and apparatus for making same

ABSTRACT

Embodiments of the present invention are directed to methods, apparatus and articles of manufacture that feature omega-3 fatty acids co-processed with flavonoid and lipophilic antioxidants for improved stability.

RELATED APPLICATIONS

This application is a 35 U.S.C. §371 filing of International ApplicationNo. PCT/US2014/068528, filed Dec. 4, 2014, which claims priority to U.S.Provisional Application Ser. No. 61/913,048, filed Dec. 6, 2013, whichis incorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERAL FUNDING

Embodiments of the present invention were not conceived or reduced topractice under Federal sponsorship or funding.

FIELD OF THE INVENTION

Embodiments of the present invention relate to medicaments and dietaryand food supplements which feature omega-3 fatty acids.

BACKGROUND OF THE INVENTION

Omega-3 fatty acids, as used herein, refers to a family of relatedcompounds with about nine members of which eicosapentaenoic acid (EPA)and docosahexaenoic acid (DHA) are two of the more common. Omega-3 fattyacids have been shown to reduce the risk of heart disease by loweringchronic inflammation and reducing high triglycerides and have a positiveeffect on children's development when consumed in high enough doses.Omega-3 fatty acids have a positive effect on certain mental illnesses,autoimmune diseases, joint complaints, weight control/fat metabolism andvisual acuity. Omega-3 fatty acids are instrumental in a variety of geneexpressions.

Despite these positive effects and the suggestion from a number ofhealth organizations that people should increase their intake of omega-3fatty acids, the average consumption of omega-3 fatty acids is twentypercent of the dosage recommended by the American Heart Association.

One problem associated with omega-3 fatty acids is the off-taste andodor associated with oxidized fatty acids. Oxidized fatty acids, andespecially oxidized omega-3s, are thought to be less effective or of nobeneficial effect since the oxidation process will create chemicalchanges to the core properties of molecules. Oxidized fatty acids may beeven be harmful. The family of compounds comprising omega-3 fatty acidsis complex and is normally derived from natural sources, such as seaplants, algae, or fish oil. As used herein, the term “fish oil” refersto oils derived from marine animal sources and is not intended to limitthe source to a particular phyletic group. It is intended to encompass,without limitation, oils derived from fish bodies, livers, intestines,heads, eyes, rows or gonads and krill, anchovy, calamari (octopi), sharkor seals.

These oils are difficult to process, store and maintain in non-oxidizingconditions. It would be desirable to have omega-3 fatty acid articles ofmanufacture that can be used in medicaments and dietary and foodsupplements that have a low concentration of oxidized fatty acids andwill resist oxidation.

SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to articles ofmanufacture, methods of making such articles and apparatus for makingsuch articles. Articles of manufacture of the present invention arecompositional in nature, comprising lipids having a high concentrationof omega-3 fatty acids and hydrophilic flavonoids. Embodiments of thepresent invention feature omega-3 fatty acid from naturally occurringsources, for example, fish and marine animal, plant and algal sources. Afurther aspect of the article of manufacture further compriseslipophilic anti-oxidants. The flavonoids and antioxidants stabilize andprevent oxidation of the omega-3 fatty acids.

As used herein, the term “flavonoid.” refers to a broad group ofsecondary plant metabolites and includes bioflavonoids, isoflavonoidsand neoflavonoids. Bioflavonoids share a flavone molecular structure,isoflavonoids are derived from an isoflavan structure and neoflavonoidshave a neoflavonoid structure. All of these structures have three ringsin which two rings are heterocycles with one phenyl group extending fromdiffering positions of the heterocycle, One of the positions of theheterocycle ring bearing the phenyl group is oxygen and a second oxygenis present in flavone and neoflavonoid structures.

In one aspect, the present invention features flavonoids derived fromone or more of the sources selected from tea, moringa and cacao. Forexample, the leaves, extracts and powders of such sources are used as amaterial co-processed with the source materials for the omega-3 fattyacids. The leaves, extracts and powders are sources for one or moreflavonoids including, without limitation (−) epicatechin, (−)epicatechin gallate, quercetin and epigallocatechin gallate (EGCG). Thehydrophilic flavonoids are present in the article of manufacture in aconcentration of between 250 to 10,000 ppm, or 500 to 2,000 ppm, orabout 1,000 ppm.

In one aspect, the article of manufacture features one or more oflipophilic anti-oxidants selected from the group consisting ofalpha-tocopherol (vitamin E), retinol (vitamin A), carotenoids(astaxanthin, lutein and zeaxanthin) and derivatives and cholecalciferol(vitamin D₃) and − derivatives. By way of example, without limitation,vitamin E and derivatives refers to such compounds exhibiting vitaminE-like activity such as alpha, beta, gamma and delta tocopherols andtocotrienols. By way of example without limitation, vitamin D andderivatives refers to such compounds exhibiting vitamin D-like activitysuch as ergosterol, 7-dehydrocholesterol, ergocalciferol andcholecalciferol. By way of example, without limitation, vitamin A andderivatives refers compounds exhibiting vitamin A-like activity such asretinol, beta carotene and other carotenoids, including, withoutlimitation, astaxanthin lutein and zeaxanthin and various pro-vitamin Acompounds.

In one aspect, the article of manufacture features melatonin in anamount sufficient to inhibit the lipid destroying (oxidation) reactionof enzymes released in the manufacturing process. The concentration ofmelatonin is determined and brought to a predetermined level to producea standard amount in the refined omega-3 oils.

In one aspect, the article of manufacture features lipophilicantioxidants derived from natural sources. For example, food sourcesrich in such compounds such as, by way of example without limitation,carrots and high value leafy green vegetables or marine sources likeshrimp and shrimp-like animals, by way of example, Calanus finmarchicus.Or, the anti-oxidants are obtained from non-natural sources. Embodimentsof the present invention feature anti-oxidants added to the sourcematerials for the omega-3 fatty acids and co-processed with the fattyacids. The resulting article of manufacture has lipophilic anti-oxidantspresent in a concentration of between 250 to 10,000 ppm, or 500 to 2,000ppm, or about 1,000 ppm.

In one aspect, the article of manufacture is incorporated in a foodproduct, or incorporated in a dosage form for administration as adietary and/or health supplement or as a medicament. For example,without limitation, the food product, dietary or health supplement, ormedicament may comprise an omega-3 fatty acid oil for oraladministration in a dosage of about 750 to 4000 mg.

A further embodiment of the present invention is directed to a method ofmaking an omega-3 article of manufacture. The method comprises the stepsof combining a source of omega-3 fatty acid having a aqueous componentand an oil component with one or more sources of flavonoids prior to orconcurrent with separating the water component from the oil component;and, separating the water component from the oil component to form anomega-3 fatty acid fraction. The omega-3 fatty acid fraction is used toform an omega-3 article of manufacture.

One aspect of the present method features omega-3 fatty acid fromnaturally occurring sources, for example, fish and marine animal, plantand algal sources. The flavonoids stabilize and prevent oxidation of theomega-3 fatty acid. The hydrophilic flavonoids are present in thearticle of manufacture in a concentration of between 250 to 10,000 ppm,or 500 to 2,000 ppm, or about 1,000 ppm.

One aspect of the present method features the source of flavonoidscomprising naturally occurring sources such as, by way of examplewithout limitation, leaves, powders and extracts of green tea, cacao andmoringa. The source of flavonoids is combined with the source of omega-3fatty acids, for example, with whole fish, fish parts plant or algalmaterials, and/or combined when whole fish, fish parts plant and/oralgal materials are rendered into small particles by means of mincing orgrinding, and/or combined as the fish, fish parts plant or algalmaterials are pressed to remove oil and water components, and orcombined with the oil and water components.

In one aspect, the method features a step of combining the source ofomega-3 fatty acid with one or more lipophilic antioxidants prior to orconcurrent with the separating step. In one aspect, the article ofmanufacture features lipophilic antioxidants derived from naturalsources. For example, food sources rich in such compounds such as, byway of example without limitation, carrots and high value green leafyvegetables, shrimp and shrimp-like marine animals or their extracts. Or,the anti-oxidants are obtained from non-natural sources. Embodiments ofthe present invention feature anti-oxidants added to the sourcematerials for the omega-3 fatty acids and co-processed with the fattyacids. That is, the lipophilic antioxidants are combined with the sourceof omega-3 fatty acids, for example, combined with whole fish, fishparts, plant or algal materials, and/or combined the as whole fish, fishparts, plant and/or algal materials are rendered into small particles bymeans of mincing or grinding, and/or combined as the fish, fish parts,plant or algal materials are pressed to remove oil and water components,and or combined with the oil and water components.

The resulting article of manufacture has lipophilic anti-oxidantspresent in a concentration of between 250 to 10,000 ppm, or 500 to 2,000ppm, or about 1,000 ppm.

In one aspect the method further comprises the step of adding an amountof melatonin sufficient to inhibit the lipid destroying (oxidation)reaction caused by the release of enzymes during the mincing, grinding,purification and refining steps. The concentration of melatonin duringone or more of these steps is monitored to ensure sufficient levels. Theconcentration of melatonin in omega-3 oils is set to a predeterminedvalue, allowing the standardization of the ratio of melatonin in omega-3oils.

In one aspect the method further comprises a step of purifying theomega-3 fraction to form a purified omega-3 fraction. Preferably, themethod is performed in a substantially continuous process withoutintervening freeze and thawing steps or storage. In one aspect themethod is performed substantially at temperatures not exceeding about 99degrees centigrade, and more preferably not greater than 40 degreescentigrade.

A further embodiment of the present invention is directed to anapparatus for forming an omega-3 article of manufacture. The apparatuscomprises means for forming a particulate omega-3 material, means forforming an omega-3 fraction, and one or more flavonoid reservoirs. Theflavonoid reservoir is in communication with one or more of the meansfor forming a particulate omega-3 material and means for forming anomega-3 fraction, to place flavonoids and/or melatonin in at least oneof the means to allow the omega-3 source material and/or omega-3fraction to be co-processed with the flavonoids and/or melatonin.

In one aspect, the apparatus further comprises means for forming aseparated omega-3 fraction. The means for forming a purified omega-3fraction is in communication with the flavonoid reservoir to placeflavonoids and/or melatonin into the omega-3 fraction prior to orconcurrent with the further purification and forming a purified omega-3fraction. One aspect features monitoring the concentration of melatoninin the omega-3 fractions and adding melatonin to a predeterminedconcentration to standardize the resultant omega-3 oil fraction.

In one aspect the apparatus is maintained at or operates at atemperature not exceeding 99 degrees centigrade and more preferably notgreater than about 40 degrees centigrade.

In one aspect, the means for forming a particulate omega-3 material isin communication with means for forming a omega-3 fraction to pass aparticulate omega-3 material to said means for forming an omega-3fraction in a substantially closed process. Similarly, a preferredapparatus has the means for forming an omega-3 fraction in communicationwith means for forming a separated omega-3 fraction to pass an omega-3fraction to the means for forming a purified omega-3 fraction.

A further embodiment of the present apparatus features a means foradding one or more lipophilic anti-oxidants to the omega-3 fraction. Oneembodiment featured a carotenoid reservoir in communication with one ormore means for forming a particulate omega-3 material and means forforming an omega-3 to place carotenoids in at least one of the means toallow the omega-3 source and an omega-3 fraction to be co-processed.

Thus, the apparatus performs the steps in a process to form a purifiedomega-3 fraction in a continuous manner, in a substantially closed,temperature controlled, environment. Such closed, temperaturecontrolled, environment allows the resultant omega-3 fatty acid articleof manufacture be made with consistent potency and substantially free ofoxidized fatty acids.

One aspect of the present invention features an apparatus that is mobileor capable of being carried on ships or trucks receiving shipsharvesting fish, marine animals, plants or algae for processing andmaking omega-3 fatty acid articles of manufacture.

These and other features and advantages will be apparent to thoseskilled in the art upon viewing the figures which are described brieflybelow and studying the text describing the invention in greater detailthat follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a, 1b and 1c depict the chemical structure of bioflavonoids,isoflavonoids and neoflavonoids, respectively;

FIG. 2 depicts in schematic form, an apparatus for forming omega-3 fattyacid articles of manufacture of the present invention; and,

FIG. 3 depicts in schematic form an apparatus for forming omega-3 fattyacid articles of manufacture of the present invention from fishmaterials.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention will be described in detail withrespect to an article of manufacture of a compositional nature,comprising omega-3 fatty acids and hydrophilic flavonoids. Theflavonoids and antioxidants stabilize and prevent oxidation of theomega-3 fatty acids. The present discussion features the preferredembodiments and the best method of carrying out aspects of the inventionwith the understanding that the embodiments considered preferred or thebest mode may change over time.

Embodiments of the present invention feature omega-3 fatty acid fromnaturally occurring sources, for example, fish and marine animal, plantand algal sources. Plant sources comprise such plants and plant partsfrom which olive oil, soybean oil, canola oil, high oleic safflower oil,sunflower seed oil, flaxseed oil, coconut oil, corn oil, cottonseed oil,peanut oil, evening primrose oil borage oil and blackcurrant oil arederived. Fish and marine animal sources comprise such animal and animalparts from which cod liver oil, salmon oil, tuna oil, krill oil, Calanusfinmarcicus oil, cod oil, herring oil, mackerel oil, anchovy oil,sardine oil menhaden oil and shark liver oil is derived.

As used herein, the term, “melatonin” refers toN-acetyl-5-methoxytryptamine and its isomers. Melatonin is a smallubiquitous molecule that acts as a hormone and anti-oxidant in mammalcells. It is produced throughout the body and found in highconcentrations in the gut, liver and bile where it is believed toprotect the gastro-intestinal tract from being destroyed by the harshdigestive milieu.

Melatonin is also found in many plants and fish where it is believed tobe important companion to lipids to protect them from being oxidized byfree radicals. Cod liver is very rich in omega-3 fatty acids. It alsocontains significant amounts of melatonin and its natural isomers. Thiscan explain why cod liver oil in traditional medicine (before the use ofmodern industrial production methods) was especially known for ananti-pain or arthritis effect since the melatonin family also has verypotent anti-inflammation effects that work in conjunction with theomega-3 oils.

As defined herein the term “flavonoid” refers to a broad group ofsecondary plant metabolites and includes bioflavonoids, isoflavonoidsand neoflavonoids. Bioflavonoids share a flavone molecular structure asdepicted in FIG. 1a . Isoflavonoids are derived from an isoflavanstructure as best seen in FIG. 1b . Neoflavonoids have a neoflavonoidstructure as depicted in FIG. 1c . These structures have three rings inwhich two rings are heterocycles with one phenyl group extending fromdiffering positions of the heterocycle. One of the positions of theheterocycle ring bearing the phenyl group is oxygen and a second oxygenis present in flavone and neoflavonoid structures.

The present invention features flavonoids derived from one or more ofthe sources selected from tea, moringa and cacao. For example, theleaves, extracts and powders of such sources are used as a materialco-processed with the source materials for the omega-3 fatty acids. Theleaves, extracts and powders are sources for one or more flavonoidsincluding, without limitation (−) epicatechin, (−) epicatechin gal late,quercetin and epigallocatechin gallate (EGCG).

As another aspect of the present invention, the article of manufacturecomprises omega-3 fatty acids and hydrophilic flavonoids and lipophilicantioxidants, for example carotenoids.

The leaves extracts and powders are co-processed in the sense that thesource materials for the omega-3 fatty acids and the source materialsfor the flavonoids are combined and mixed. For example, withoutlimitation, turning now to FIG. 2, an apparatus for forming an omega-3article of manufacture, generally designated by the numeral 11 isdepicted.

The apparatus 11 comprises the following major elements, means forreceiving sources of omega-3 fatty acids 15, means for forming aparticulate omega-3 material 17, means for forming a omega-3 fraction19, and means for separating the omega-3 fatty acid fraction 21, omega-3fatty acid flavonoid storage means 23 and flavonoid reservoir 25.

The means for receiving sources of omega-3 fatty acids 15 may takeseveral forms and comprise a reservoir, hopper, container, vessel or thelike for holding, by way of example, fish and fish parts. Thisdiscussion will use the term means for receiving sources of omega-3fatty acids and hopper 15 interchangeably. The hopper 15 is incommunication with means for forming a particulate omega-3 material 17.

As used herein, the term “communicate” and “in communication with”refers to connected to for material transfer, by means of a conveyorbelt, auger, conduit or other means known in the art. Communicationbetween hopper 15 and means for forming a particulate omega-3 material17 is depicted by the conduit 29 a.

Means for forming a particulate omega-3 material 17 is, where thematerial is fish, fish parts, or other plant or animal materials, one ormore mincers, cutters and/or grinders, in a suitable container. Thoseskilled in the art will recognize that features of the hopper 15 can beincorporated into the means for forming a particulate omega-3 material17. That is, the means 17 and the hopper 15 can be a single unitarystructure. This discussion will refer to the means for forming aparticulate omega-3 material 17 interchangeably with the term, mincer.

Mincer 17 is in communication with means for forming an omega-3 fraction19 via conduit 29 b. Means for forming an omega-3 fraction 19 comprise,by way of example, without limitation, presses, dissolution and orsolubilizers, which release the liquid fractions form the cellularsolids. Such means for forming an omega-3 fraction are contained in asuitable vessel. This discussion will refer to means for forming anomega-3 fraction 19 interchangeably with the term press 19.

Press 19 is in communication via conduit 29 c with means for separatingan omega-3 fraction 21. Means for separating an omega-3 fraction 21 is avessel for receiving the liquids produced from the press 19. The liquidcomprises an aqueous fraction and an oil fraction, which oil fractioncomprises in whole or in part, omega-3 fatty acids. The aqueous fractionand oil fractions separate and the oil fraction is removed via conduit29 d to a storage vessel 23. Aqueous fractions are removed via an exitport 31.

Storage vessel 23 may comprise individual product containers forfinished omega-3 fatty acids or larger vessels holding omega-3 fattyacids for further processing and/or refinement.

The flavonoid reservoir 25 is in communication with one or more of themeans for receiving omega-3 source material 15, means for forming aparticulate omega-3 material 17, means for forming an omega-3 fraction19, and means for separating an omega-3 fraction 21 via conduits 35 a,35 b, 35 c and 35 d. The source material for the flavonoids, forexample, without limitation, leaves and other plant material from tea,moringa and/or cacao are stored in the reservoir 25. The flavonoidreservoir 25 places flavonoids in at least one of the means 15, 17, 19,and 21 to allow the omega source material and/or omega-3 fraction to beco-processed with the flavonoids. The flavonoid reservoir 25 may also beplaced in communication via conduits and the like [not shown] with thestorage vessel 23.

In one embodiment the flavonoids are added to the means for receiving anomega-3 source material 15 and co-processed through mincing. That is,the flavonoid materials are minced and ground with the omega-3 sourcematerial to form a particulate admixture. This admixture is processedthrough pressing carrying forward the flavonoids in the liquid. Theliquid is processed through fractionation and separation of fractions.And, each individual step of mincing, pressing, fractionation andseparation can be supplemented with added flavonoid source material asthe materials move through the apparatus 11.

During the first stage of rendering of fish oil, the fish tissue iscrushed and there is a subsequent massive liberation of enzymes thatstart decomposing the lipids. Melatonin, when in sufficient amounts, caninhibit this lipid destroying (oxidation) reaction. Apparatus 11 hasmeans for monitoring [not shown] and adjusting levels of melatoninduring refining. That is, melatonin is added to the flavonoid reservoir25, or the apparatus comprises a separate melatonin reservoir andmetering pump [not shown] or the melatonin is added through thelipophilic anti-oxidant reservoir to be described more fully below.

Present day fish oil refining methods use acid/alkali washing, organicchemicals and high heat which diminish the oil's natural content ofmelatonin and its isomers making the oil less nutrient rich and alsomore susceptible to oxidation. The present invention avoids thesemelatonin depleting steps and the nutrient content monitoring systemalso allows for adjusting the melatonin level throughout the refining.The finished oil will have a standardized melatonin level that reflectsor enhances the fish oil's basal value. Since omega-3 to melatonin ratiois believed to be important for fish oils' therapeutic effects, thepresent invention allows for standardizing this ratio in the finishedoil independently of the specie's original ratio or starting values. Forexample, without limitation one would monitor the concentration ofmelatonin and adjust the level of fish parts and the like to greaterthan 800 picogram melatonin per gram of tissue. With respect to liquidsreleased from such fish parts, one would monitor the concentration ofmelatonin in such liquids and adjust to a level of 30,000 picogrammelatonin per milliliter of liquid.

One embodiment of the apparatus 11 further comprises a lipophilicantioxidant reservoir [not shown]. Lipophilic antioxidants may, by wayof example, without limitation, comprise members of carotenoid familylike astaxanthin extract from krill or Calanus finmarchicus or lutein orbeta carotenes from plant sources. The flavonoid reservoir 25 may alsoserve this function, that is, it may hold flavonoid material andlipophilic antioxidant material. The lipophilic antioxidant reservoirdischarges lipophilic antioxidant material to the one of more, or all,of the hopper 15, mincer 17, press 19 means for separating a omega-3fraction 21 and the storage vessel 23. Thus, the lipophilic antioxidantmaterial is co-processed with the omega-3 source material through thereceiving and through finished or semi-finished product.

The lipophilic anti-oxidants are selected from the group consisting ofalpha-tocopherol (vitamin E), retinol (vitamin A) carotenoids andderivatives and derivatives and cholecalciferol (vitamin D₃) andderivatives. The lipophilic antioxidants may be derived from naturalsources, for example, food sources rich in such compounds such as, byway of example without limitation, carrots and high value green leafyvegetables and marine sources like krill or Calanus fintnarchicus. Or,the anti-oxidants are obtained from non-natural sources.

In one aspect, the apparatus 11 further comprises means for forming apurified omega-3 fraction [not shown] which can be integral with orseparate from storage vessel 23. The means for forming a purifiedomega-3 fraction is in communication with the flavonoid reservoir 25 toplace flavonoids into the omega-3 fraction prior to or concurrent withthe further purification and forming a purified omega-3 fraction.

The apparatus 11 is maintained at or operates at a temperature notexceeding 99 degrees centigrade and more preferably not greater thanabout 40 degrees centigrade by suitable heating and cooling equipmentknown in the art. Thus, the apparatus 11 defines a substantially closed,temperature controlled system, receiving source material in the form ofmaterials having omega-3 fatty acids, flavonoids and lipophilicantioxidants and processing such materials through to a purified omega-3fraction. Apparatus 11 is preferably sized to be mobile or capable ofbeing carried on trucks receiving ships harvesting fish, marine animals,plants or algae for processing and making omega-3 fatty acid articles ofmanufacture and on ships themselves. Thus, close to the harvesting ofsource material for omega-3 fatty acids, the apparatus 11 producesarticles of manufacture having little oxidation.

The hydrophilic flavonoids may preferentially partition into the waterphase but remain present in the omega-3 fatty acid fraction in aconcentration of between 250 to 10,000 ppm, or 500 to 2,000 ppm, orabout 1,000 ppm. The lipophilic antioxidants may preferentiallypartition into the fatty acid phase and are present in the omega-3 fattyacid fraction in a concentration of between 250 to 10,000 ppm, or 500 to2,000 ppm, or about 1,000 ppm.

The presence of the flavonoids and lipophilic antioxidants early in theprocessing of the source material for the omega-3 fatty acids preventsoxidation and spoilage of the omega-3 fatty acids.

Turning now to FIG. 3, an apparatus for processing raw fish, generallydesignated by the numeral 111, is depicted. The apparatus 111 hasfollowing major elements, means for receiving sources of omega-3 fattyacids 115, means for forming a particulate omega-3 material 117, meansfor forming a omega-3 fraction 119, and means for separating the omega-3fatty acid fraction 121, omega-3 fatty acid flavonoid storage means [notshown] and flavonoid reservoir 125.

The means for receiving sources of omega-3 fatty acids 115 is anassembly of parts comprising such parts and assembly [not shown] leadingup to a fish hopper 131. The parts and assembly may comprise fishsorters and fish sizing means known in the art. The fish hopper 131 isin communication with means for forming a particulate omega-3 material117 by means of a conduit 135 a. Conduit 135 a may further compriseaugers, moving belts or turntables and other means for transporting fishor fish parts to means for forming a particulate omega-3 material 117.

Fish hopper is of a conventional design and available from numerousvendors. Fish raw material is conveyed from the fish hopper 131 to thedeboner 133 via conduit 135 a

Means for forming a particulate omega-3 material 117 is an assembly ofparts comprising a deboner 133, a buffer hopper 137, first gear pump139, static mixer 141 and buffer tank 143; linked by suitable conduits135 a through 135 g. Deboner 133 and buffer hopper 137 are ofconventional design and available from numerous vendors. Deboner 133receives the fish material and minces the soft parts of the fishmaterial and separates the solids and removes them from the processstream. Liquids are passed to buffer hopper 137 via conduit 135 b.Buffer hopper 137 is a substantially closed vessel flushed withnitrogen. Buffer hopper 137 is in communication with first gear pump 139via conduit 135 c. First gear pump 139 powers the liquid through 135 dto analytical element 145 a and flow meter 145 b, to be described ingreater detail in the discussion that follows. A conduit 135 d′ isdepicted between the analytical element 145 a and the flow meter 145 b.Those skilled in the arts will recognize that the relative positions offlow meter 145 b and analytical element 145 a can be reversed. And, flowmeter 145 b and analytical element 145 a can be located in differentparts of the flow stream or additional flow meters and analyticalelements [not shown] can be placed in the flow stream. Flow meter 145 b,static mixer 141 and buffer tank 143 are in fluid communication viaconduits 135 e and 135 f.

Analytical element 145 a and flow meter 145 are in signal communicationwith control means 151 as represented by dotted lines. The analyticalelement 145 a monitors the water content and the total mass of theminced material. The flow meter 145 b monitors the flow of omega-3source material. As used herein, control means refers to computer,analog or digital type automated control system. Digital control systemscomprise, by way of example, without limitation, computer processingunits (CPUs) well known in the art, including integral CPUs and externalCPUs of the type found in computers, laptops, mainframes, servers andhand-held computer devices, all well known in the art and available fromnumerous vendors. The term “signal communication” refers to data orcommand signals in the sense of to power or to send. For example,without limitation, such signal communication comprises wired togetherelectronically, electro-magnetic signaling by means of radio, infrared,optical, acoustic communication, WIFI and the like.

The flavonoid reservoir 125 is in communication with one or more of themeans for receiving omega-3 source material 115, means for forming aparticulate omega-3 material 117, means for forming an omega-3 fraction119, and means for separating an omega-3 fraction 121. As depictedflavonoid reservoir 125 is in fluid communication with the means forforming a particulate omega-3 material via conduit 153 which is incommunication with static mixer 141. A metering pump 155 is interposedinto conduit 153 to precisely add the flavonoid material into staticmixer 141. The source material for the flavonoids, for example, withoutlimitation, leaves and other plant material from tea, moringa and/orcacao or extracts or powders or reconstituted liquids thereof is storedin flavonoid reservoir 125.

The metering pump 155 is in signal communication with control means 151and is activated in response to the flow of omega-3 source materialflowing past flow meter 145 b and the content of the material asdetermined by analytical element 145 a. Thus, the omega-3 sourcematerial flowing through the apparatus 111 is monitored and flavonoidsource material is added to the flow, automatically, to levels set bythe operator.

Flavonoid reservoir 125 may also receive and contain lipophilicantioxidants which are added simultaneously with flavonoids. Or, aseparate reservoir for lipophilic antioxidants [not shown] and aseparate metering pump [not shown] may be provided in communication withconduits and static mixer 141 or other parts and components of theapparatus 111. Such metering pump is in signal communication with thecontrol means to add lipophilic antioxidants in response to the flowrate and the content of the liquids flowing through the apparatus 111.Thus, flavonoids and lipophilic antioxidants are added to the omega-3source material early in the process and with precision to produce aconsistent stable omega-3 fatty acid.

Buffer tank 143 is in communication with means for adjusting pH [notshown] and provides further mixing of the liquid containingparticulates. Buffer tank 145, of the means for forming a particulateomega-3 material 117, is in fluid communication with means for formingan omega-3 fraction 119, via conduit 135 g leading to second gear pump157.

Means for forming an omega-3 fraction 119 comprises an assembly of partsincluding second gear pump 157, first controlled thermal tank 159 a andsecond controlled thermal tank 159 b and tricanter feed tank 163. Secondgear pump 157 communicates with first controlled thermal tank viaconduit 135 h. First controlled thermal tank 159 a and second controlledthermal tank 159 b are in fluid communication via conduit 135 i. Thesecond controlled thermal tank 159 b is in fluid communication withtricanter feed tank 163.

The second gear pump 157 propels the fluids through the means forforming an omega-3 fraction 119. The first controlled thermal tank 159 aand second controlled thermal tank 159 b adjust the temperature of theliquids to promote separation into fractions. The tricanter feed tank163 maintains the fractions, with suitable mixing, until the fluids arereceived by means for separating an omega-3 fraction 121 via conduit135K.

Means for separating an omega-3 fraction 121 comprises an assembly ofparts comprising third gear pump 165 and tricanter 167. Tricanter feedtank is in fluid communication with third gear pump 165 via conduit 135k. Third gear pump 165 is in fluid communication with tricanter 167 viaconduit 135 l. Third gear pump 165 powers the fluids comprising anaqueous fraction and an oil fraction, which oil fraction comprises inwhole or in part, omega-3 fatty acids, into the tricanter 167. Tricanter167 separates the solids, aqueous fraction and oil fractions. The solidare removed via solids conduit 171. The aqueous fraction, rich inprotein is removed via aqueous conduit 173. The oil fraction is removedvia conduit 175 to means for storing or further processing an omega-3fatty acid 123.

Means for storing an omega-3 fatty acid [not shown] may compriseindividual product containers for finished omega-3 fatty acids or largervessels holding omega-3 fatty acids for further processing and/orrefinement. Such individual containers and larger vessels are known inthe art and are omitted from this drawing for clarity.

The article of manufacture, an omega-3 fatty acid having flavonoids andlipophilic antioxidants is incorporated in a food products, orincorporated in a dosage forms for administration as a dietary and/orhealth supplement or as a medicament. For example, without limitation,the food product, dietary or health supplement, or medicament maycomprise an omega-3 fatty acid oil for oral administration in a dosageof about 750 to 4000 mg. The omega-3 fatty acid oil is stable andessentially free of fish odors and free of fish tastes. The healthbenefit of omega-3 fatty acids can be obtained synergistically withother medicaments with the omega-3 fatty acid serving as a base forincorporating the medicaments in a suitable dosage form.

Embodiments of the present method will now be described in detail withrespect to a method of making an omega-3 article of manufacture with theapparatus 11, as depicted in FIG. 2. A source of omega-3 fatty acidhaving a aqueous component and an oil component, such as fish and fishparts, is placed in hopper 15 with one or more sources of flavonoidsfrom flavonoid reservoir 25 and one or more sources of lipophilicantioxidants from an antioxidant reservoir [not shown]. By way ofexample without limitation, a source of flavonoids, leaves, powders andextracts of green tea, cacao and moringa, is combined with the source ofomega-3 fatty acids, for example, combined with whole fish, fish partsplant or algal materials, and source material for lipophilicantioxidants, to form an admixture.

The admixture is passed to the mincer 17 and rendered into smallparticles by means of mincing or grinding to form a particulateadmixture. The particulate admixture is passed to the press 19 and theparticulate admixture pressed to produce a liquid having oil and watercomponents. The liquid having oil and water components is passed to theseparation vessel 21 to form an oil fraction and a water fraction. Eachof these steps is potentially supplemented with additional flavonoidmaterial, melatonin and lipophilic antioxidants.

The omega-3 fatty acid fraction is passed to storage vessel 23 as afinished product or subjected to further refining and processing.

The flavonoids and/or melatonin stabilize and prevent oxidation of theomega-3 fatty acid. The hydrophilic flavonoids are present in thearticle of manufacture in a concentration of between 250 to 10,000 ppm,or 500 to 2,000 ppm, or about 1,000 ppm. The resulting article ofmanufacture has lipophilic anti-oxidants present in a concentration ofbetween 250 to 10,000 ppm, or 500 to 2,000 ppm, or about 1,000 ppm. Onepreferred standard concentration of melatonin corresponds to an amountequal to or greater than melatonin levels in cod liver oil. Theflavonoids, melatonin and/or lipophilic antioxidants are presentthroughout the process and prevent oxidation of the omega-3 fatty acidsfrom the earliest point of processing.

Thus, embodiments of the present invention have been described in detailwith the understanding that such description is directed to preferredembodiments and what is now considered to be the best mode of practicingthe invention. However, embodiments of the present invention are capableof modification and alteration without departing from the teachingherein, such that the present invention should not be limited to thedetails herein but should encompass the subject matter of the claimsthat follow and their equivalents.

The invention claimed is:
 1. An apparatus for forming an omega-3 articleof manufacture from an omega-3 source material, an omega-3 fraction, anda separated omega-3 fraction comprising: means for forming a particulateomega-3 material, means for forming an omega-3 fraction, means forseparating an omega-3 fraction, one or more flavonoid reservoirs and oneor more melatonin reservoirs, said one or more flavonoid reservoirs andone or more melatonin reservoirs being in communication with one or moreof said means for forming a particulate omega-3 material, means forforming an omega-3 fraction, and means for separating an omega-3fraction; means to place flavonoids and a concentration of melatonin inat least one of said means for forming a particulate omega-3 material,said means for forming an omega-3 fraction, and said means forseparating an omega-3 fraction; and means for monitoring and adjustingthe concentration of melatonin placed in one or more of the groupcomprising the omega-3 source material, the particulate omega-3material, the omega-3 fraction, and the separated omega-3 fraction bythe means to place flavonoids and a concentration of melatonin, whereinthe means for forming a particulate omega-3 material allows said omega-3source material, said omega-3 fraction and said separated omega-3fraction to be co-processed with said flavonoids and the concentrationof melatonin.
 2. The apparatus of claim 1 wherein said means aremaintained at a temperature not exceeding 99 degrees centigrade.
 3. Theapparatus of claim 1 wherein said means for forming a particulateomega-3 material is in communication with said means for forming aomega-3 fraction to pass a particulate omega-3 material to said meansfor forming an omega-3 fraction, and said means for forming an omega-3fraction is in communication with said means for separating an omega-3fraction to pass an omega-3 fraction to said means for separating anomega-3 fraction.
 4. The apparatus of claim 1 wherein apparatus performssteps in a process to form a separated omega-3 fraction in a continuousmanner.
 5. The apparatus of claim 1 wherein said means are located on awater vessel which procures sources of omega-3 material from naturalsources.
 6. The apparatus of claim 1 wherein said means are mounted on atruck bed.
 7. The apparatus of claim 1 wherein said means are mounted ona water vessel.
 8. The apparatus of claim 1, wherein the means to placeflavonoids and the concentration of melatonin places flavonoids and theconcentration of melatonin into the omega-3 fraction prior to orconcurrent with forming a particulate omega-3 material.
 9. The apparatusof claim 1, wherein the means for monitoring and adjusting theconcentration of melatonin regulates to a concentration of melatoninthat is substantially equal to or greater than melatonin levels in codliver oil.
 10. An apparatus for forming an omega-3 article ofmanufacture from an omega-3 source material, an omega-3 fraction, and aseparated omega-3 fraction comprising: means for forming a particulateomega-3 material, means for forming an omega-3 fraction, means forseparating an omega-3 fraction, one or more melatonin reservoirs incommunication with one or more of said means for forming a particulateomega-3 material, means for forming an omega-3 fraction, and means forseparating an omega-3 fraction; means to place a concentration ofmelatonin in at least one of said means for forming a particulateomega-3 material, means for forming an omega-3 fraction, and means forseparating an omega-3 fraction; and means for monitoring and adjustingthe concentration of melatonin placed in one or more of the groupcomprising the omega-3 source material, the particulate omega-3material, the omega-3 fraction, and the separated omega-3 fraction,wherein the means for forming a particulate omega-3 material allows saidomega-3 source material, said omega-3 fraction, and said separatedomega-3 fraction to be co-processed with said concentration ofmelatonin.
 11. The apparatus of claim 10 further comprising: one or moreflavonoid reservoirs in at least one of said means for forming aparticulate omega-3 material, means for forming an omega-3 fraction, andmeans for separating an omega-3 fraction; and means to place flavonoidsin at least one of said means for forming a particulate omega-3material, means for forming an omega-3 fraction, and means forseparating an omega-3 fraction, wherein the means for forming aparticulate omega-3 material further allows said omega-3 sourcematerial, said omega-3 fraction, and said separated omega-3 fraction tobe co-processed with said flavonoids.
 12. The apparatus of claim 10wherein said means are maintained at a temperature not exceeding 99degrees centigrade.
 13. The apparatus of claim 10 wherein said means forforming a particulate omega-3 material is in communication with saidmeans for forming a omega-3 fraction to pass a particulate omega-3material to said means for forming an omega-3 fraction and said meansfor forming an omega-3 fraction is in communication with said means forseparating an omega-3 fraction to pass an omega-3 fraction to said meansfor separating an omega-3 fraction.
 14. The apparatus of claim 10wherein apparatus performs steps in a process to form a separatedomega-3 fraction in a continuous manner.
 15. The apparatus of claim 10wherein said means are located on a water vessel which procures sourcesof omega-3 material from natural sources.
 16. The apparatus of claim 10wherein said means are mounted on a truck bed.
 17. The apparatus ofclaim 10, wherein the means to place the concentration of melatoninplaces the concentration of melatonin into the omega-3 fraction prior toor concurrent with forming a particulate omega-3 material.
 18. Theapparatus of claim 10, wherein the means for monitoring and adjustingthe concentration of melatonin regulates to a concentration of melatoninthat is substantially equal to or greater than melatonin levels in codliver oil.